Exception to Code for extemporaneous methadone
Ethical controls on the extemporaneous preparation of medicinal products are being relaxed for methadone mixture.
The Royal Pharmaceutical Society’s Code of Ethics and Standards
for pharmacists specifies that a prescribed medicine must be supplied
as a licensed products if such a product exists (service specification
4) and that products should only be prepared extemporaneously if no licensed
product exists (service specification 21). For methadone mixture, however,
the Society has not rigidly enforced the requirement because of its awareness
that storage of sufficient quantities of licensed product can pose difficulties
for pharmacists.
The Council has now, at the February
Council meeting, approved a policy
making an exception to the code’s requirement in the case of methadone
mixture, provided certain specific requirements are adhered to.
The problem for pharmacies with a large number of methadone patients
is that supplies of the ready-made product must be stored in a Controlled
Drug cabinet to comply with the storage requirements of the Misuse of
Drugs (Safe Custody) Regulations 1973. If the product can be prepared
extemporaneously, the storage requirements are much smaller because the
diluent used to prepare the mixture does not require safe custody until
the methadone powder is added.
In addition, the cost of branded, licensed methadone products was initially
far greater than the cost of the ingredients required to prepare methadone
extemporaneously and there was concern that requiring all pharmacists
to supply the licensed methadone products could have implications for
primary care organisations’ drug bills and could have an adverse
impact on service provision to substance misuse patients.
Lynsey Balmer, the Society’s head of professional ethics, said: “The
use of unlicensed methadone has decreased in recent years and it is now
most commonly supplied in pharmacies that have a large number of methadone
patients. The Society recognises that some of these pharmacies do not
have the capacity to store sufficient volumes of licensed methadone and
that preventing the extemporaneous preparation of methadone could result
in such pharmacies having to reduce the services they provide to substance
misuse patients. However, it is essential that robust standards and systems
are in place to ensure the quality of extemporaneously prepared methadone
so that patient care is not compromised.
“It was therefore important that the Society consider the continued
appropriateness of pharmacists preparing methadone mixture extemporaneously
when licensed
products are available, and ensures appropriate safeguards are in place.”
The Society’s new guidance on the extemporaneous preparation of
methadone mixture is published in The Journal this week as a
Law and Ethics Bulletin.
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The
Pharmaceutical Journal